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The development of non-hormonal contraceptives is critical to increase options for women. In combination with prevention against sexually transmitted infections, they can become an important component of multipurpose prevention technologies (MPTs) which address multiple reproductive health needs with a single product. Resulting from multiple rounds of expert consultations, this framework aims to guide the development of non-hormonal contraceptive MPTs. Key informant interviews with experts in family planning and HIV and STI prevention and MPT product developers and funders from around the globe were conducted, reviewed, and coded. Identified key themes were discussed by experts at the November 2019 Eunice Kennedy Shriver National Institute of Child Health and Human Development Contraceptive Development Meeting in Houston, Texas. Seven action strategies were identified to address key research gaps and priorities for advancing the field. They highlight the importance of identifying target populations, a systematic approach to collaborative research, and leveraging knowledge from other fields, including regulatory and patenting, manufacturing, and commercialization expertise. Employing expanded target product profiles and setting go/no-go decisions for non-hormonal MPTs will help to prioritize the most promising candidates in the drug development pipeline. Further, they call for optimizing investments and engagement of stakeholders from public and private sectors. These action strategies aim to facilitate collaboration and innovation amongst multidisciplinary MPT stakeholders. Paramount to success will be enhancing strategic alliances and reconciling the essential social–behavioral context and market forces that drive product use with the complexities of research and development, regulatory approval, and commercialization., The objective of this paper is to present an actionable framework that guides development of non-hormonal contraceptive MPTs.

BackgroundContinued high incidence of HIV and other STIs, paired with rising antibiotic resistance to a number of existing treatments, warrants the development of new pharmaceutical approaches for STI prevention. Multipurpose prevention technologies (MPTs) offer an innovative approach for expanding HIV/STI prevention. The majority of MPT product candidates currently in development include HIV prevention, while only half include compounds active against non-HIV STIs.MethodsThis narrative review focuses on compounds in preclinical development (in vitro and in vivo) through phase 3 clinical trials with activity against one or more of the following infections: HIV, HSV-1, HSV-2, Chlamydia trachomatis,Neisseria gonorrhoeae,Treponema pallidum, andTrichomonas vaginalis.Bacterial vaginosis is included due to its association with increased risk of STIs. The focus is on compounds with novel mechanisms of action and prophylactic and/or therapeutic potential. Articles published in PubMed between 2011 and 2021, NIH RePorter and conference abstracts and proceedings between 2020 and 2021 were searched. Excluded from the review are compounds that are already being used in MPT product candidates.Main resultsThere is a growing pipeline of compounds targeting viral STIs, many of which have successfully transitioned from preclinical to clinical stages of development. However, the product development pipeline remains limited for compounds that target bacterial STIs.ConclusionsThe paucity of new pharmaceutical approaches for STI prevention, particularly non-HIV STIs, remains a public health gap. Future funding priorities should include STI prevention research. Despite limited attention to STI prevention in the development of MPTs, many research institutions worldwide are working on discoveries of new compounds, exploring new indications for existing drugs or on innovative drug delivery mechanisms. Our findings can be used to connect researchers across the globe to advance the development of compounds that have potential as active pharmaceutical ingredients in future MPTs.

Adolescent girls and young women experience high rates of sexually transmitted infection (STI) with currently available contraceptive methods, yet few studies examine the burden of chlamydial infection by contraceptive method used.In this cross-sectional analysis, we linked July 2012-June 2013 claims from a publicly-funded family planning program in California to chlamydia laboratory test results. Female clients were classified by the most effective contraceptive method reported by providers during the year: tier 1 (high-efficacy permanent or long-acting reversible methods), tier 2 (shorter-acting hormonal methods), or tier 3 (barrier methods, emergency contraception, or natural family planning). In addition, we identified clients who received condoms from providers. We used log-binomial models to estimate adjusted prevalence ratios comparing chlamydia positivity by contraceptive method(s).Of 74,636 female clients of ages 15-29 years with chlamydia test results, 5.1% had at least one positive test during the year. Chlamydia positivity was highest among tier 2 users (5.3%) compared with 4.5% and 4.9% among tiers 1 and 3 users, respectively (p 0.001). Positivity was higher among clients who received condoms from providers than those who did not (6.3% vs. 4.3%, p 0.001). In adjusted analyses, there were no significant differences in positivity by contraceptive tier. However, clients who received condoms had 1.32 (95% confidence interval: 1.24-1.40) times the positivity of those who did not.We found high chlamydia positivity among young female family planning clients regardless of contraceptive method. The development and provision of additional Multipurpose Prevention Technologies that confer protection against both pregnancy and STIs may help to address unmet need for STI prevention.

© 2018, © 2018 The European Society of Contraception and Reproductive Health. Objective: Multipurpose prevention technologies (MPTs) are an innovative class of products that deliver varied combinations of human immunodeficiency virus (HIV) prevention, other sexually transmitted infection (STI) prevention, and contraception. Combining separate strategies for different indications into singular prevention products can reduce the stigma around HIV and STI prevention, improve acceptability of and adherence to more convenient products, and be more cost-effective by addressing overlapping risks. Methods: This article outlines a strategic action framework developed as an outcome of a series of expert meetings held between 2014 and 2016. The meetings focused on identifying opportunities and challenges for MPTs that combine hormonal contraception (HC) with antiretroviral drugs into single products. The framework aims to present an actionable strategy, by addressing key research gaps and outlining the key areas for progress, to guide current and future HC MPT development. Results: We identified eight primary action areas for the development of impactful HC MPTs, and includes aspects from epidemiology, pharmacology, clinical trial design, regulatory requirements, manufacturing and commercialisation, behavioural science, and investment needs for research and development. Conclusion: Overall, the challenges involved with reconciling the critical social-behavioural context that will drive MPT product use and uptake with the complexities of research and development and regulatory approval are of paramount importance. To realise the potential of MPTs given their complexity and finite resources, researchers in the MPT field must be strategic about the way forward; increased support among policy-makers, advocates, funders and the pharmaceutical industry is critical.

Multipurpose prevention technologies (MPTs) represent a powerful opportunity to address the unmet sexual and reproductive health needs of women in at-risk populations around the world in an efficient and cost-effective manner. The development of MPT products for the combination prevention of pregnancy and sexually transmitted infections (including HIV) is a high-risk/high-gain, expensive process. The associated challenges are compounded by limitations in available resources for the development, evaluation, and delivery of such products. Consequently, an objective process for identifying MPT products with the highest public health impact potential is necessary to serve as the basis of coordinated investment of supporting agencies in the development of such products. Moreover, this process would serve as a framework for product development organizations, guiding their product development strategies. The Scientific Agenda Working Group of the Initiative for Multipurpose Prevention Technologies conducted an MPT pipeline evaluation exercise for the purpose of defining specific MPT product priorities, and to identify MPT technology gaps which need to be addressed in order to achieve development of optimal products. Through a formal and objective process, a set of MPT priority product recommendations emerged, along with several priority MPT gaps. Further, specific MPT development process priorities were identified. The detailed process and summary findings of this exercise are presented here. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research.

This editorial seeks to convey the key points of the discussions focused on multipurpose prevention technologies that took place at an international symposium on Advancing Prevention Technologies for Sexual and Reproductive Health. It also looks to engage health care professionals in the effort to fulfill the potential that these technologies might offer. Copyright © 2010 Elsevier Inc. All rights reserved.

Microbicides for HIV/sexually transmitted infection (STI) prevention are still in development. Microbicide acceptability studies have thus focused on soliciting input from individuals about hypothetical products using traditional epidemiological and behavioral research methodologies. Here, we integrate a well-established market research method, conjoint analysis, with more traditional epidemiological and behavioral research to examine potential users' preferences for different microbicide formulations.Focus group discussions (n = 67) were held with a diverse population of young men and women (aged 18-32 years) from Northern California. Then, young women participated in structured surveys (n = 321) that included a conjoint study, a methodology not yet used in microbicide acceptability. The main outcome measures were intentions for different microbicide formulations, inferred preferences for microbicide characteristics, and self-reported risk factors for HIV, other STIs, and pregnancy.Risk of STIs and unwanted pregnancies is a concern within this population. Participants' responses suggest that the ideal microbicide would (1) offer protection from pregnancy, HIV, STIs, and vaginal infections, (2) offer as much protection as condoms, (3) allow insertion up to 8 hours prior to sexual activity, (4) be available over the counter (OTC), (5) be inserted with an applicator, and (6) have only slight leakage not requiring a panty liner. The average predicted purchase probability for this ideal microbicide was 69%.Our findings help illustrate microbicide product preferences and demand among young women in California, and the methodological approach should lend itself to other populations as well as during clinical trials when understanding product use and nonuse is critical.

This article reflects an investigation of knowledge, attitudes and behaviours and HIV/STI prevalence of Sudanese refugees and Ethiopian sex workers in 1992. It represents one of the earliest such investigations within an African refugee population. The investigation took place in the Dimma refugee settlement in south-western Ethiopia and study participants included Sudanese refugee men and women and Ethiopian female sex workers. Methods used for this investigation included focus group discussions, behavioural surveys and serologic testing. The main outcome measures of the investigation were HIV/STI knowledge, attitudes and behaviours and biological markers for HIV, syphilis and herpes simplex 2. The study findings indicate that in the early 1990s, knowledge about AIDS and condom use was low among Sudanese refugee women and not one reported having ever used a condom. Furthermore, sexual contact between refugee men and sex workers was frequent during the time of this study and the prevalence of HIV and other STIs was high. The results confirm a widely held assumption that highly mobile and transient populations in Africa are susceptible to STIs and HIV, in large part due to their knowledge, attitudes and behaviours.

BackgroundMicrobicide candidates delivered via gel vehicles are intended to coat the vaginal epithelium after application. The coating process depends on intrinsic biophysical properties of the gel texture, which restricts the potential choices for an effective product: the gel first must be physically synthesizable, then acceptable to the user, and finally applied in a manner promoting timely adequate coating, so that the user adherence is optimized. We present a conceptual framework anchoring microbicide behavioral acceptability within the fulfillment of the product biophysical requirements.MethodsWe conducted a semi-qualitative/quantitative study targeting women aged 18-55 in Northern California to assess user preferences for microbicide gel attributes. Attributes included: (i) the wait time between application and intercourse, (ii) the gel texture and (iii) the trade-off between wait time and gel texture. Wait times were assessed using a mathematical model determining coating rates depending upon the gel's physical attributes.Results71 women participated. Results suggest that women would independently prefer a gel spreading rapidly, in 2 to 15 minutes (P0.10) for use with a steady partner, a preference for a watery gel spreading rapidly rather than one having intermediate properties for use with a casual partner (P = 0.024).ConclusionsBiophysical constraints alter women's preferences regarding acceptable microbicide attributes. Product developers should offer a range of formulations in order to address all preferences. We designed a conceptual framework to rethink behavioral acceptability in terms of biophysical requirements that can help improve adherence in microbicide use ultimately enhancing microbicide effectiveness.

Lime has a long history as a contraceptive and vaginal hygiene douche, and ongoing use in Africa is documented. We report on the first safety study on diluted lime juice to assess its potential as a candidate microbicide.Twenty-five sexually abstinent women were randomly assigned to apply a 10% or 20% concentration of lime juice or 0% (water-only) through a soaked tampon once daily for 14 consecutive days. Tests for genital infections, measurement of inflammatory biomarkers, and a colposcopy were performed before and after treatment.No participant showed severe vaginal irritation. Two women developed a yeast infection after using lime juice. More than 70% of women in all groups reported side effects, most being singular, mild, and transient events. The users of 20% diluted lime juice experienced a significantly higher frequency of burning and dryness. Vaginal inflammatory biomarkers showed no significant change between preexposure and postexposure levels. The naturally low vaginal pH showed little change, and lactobacilli colonization did not decrease.Lime juice up to 20% concentration has an acceptable safety profile for vaginal use. However, as new in vitro research shows that the effectiveness of lime juice to prevent HIV transmission in concentrations lower thanor=50% is unlikely and concentrations of 50% have been shown to be toxic, women should be discouraged from commencing or continuing the vaginal use of lime juice.

This article reflects an investigation of knowledge, attitudes and behaviours and HIV/STI prevalence of Sudanese refugees and Ethiopian sex workers in 1992. It represents one of the earliest such investigations within an African refugee population. The investigation took place in the Dimma refugee settlement in south-western Ethiopia and study participants included Sudanese refugee men and women and Ethiopian female sex workers. Methods used for this investigation included focus group discussions, behavioural surveys and serologic testing. The main outcome measures of the investigation were HIV/STI knowledge, attitudes and behaviours and biological markers for HIV, syphilis and herpes simplex 2. The study findings indicate that in the early 1990s, knowledge about AIDS and condom use was low among Sudanese refugee women and not one reported having ever used a condom. Furthermore, sexual contact between refugee men and sex workers was frequent during the time of this study and the prevalence of HIV and other STIs was high. The results confirm a widely held assumption that highly mobile and transient populations in Africa are susceptible to STIs and HIV, in large part due to their knowledge, attitudes and behaviours.

A survey of 96 families in a rural region of Honduras, conducted in 1998, showed that 80 of these predominantly (95 or 96) farming families used pesticides in their work or at home. Paraquat was used most often, and safety measures were very rarely taken in its use. Seventy-seven families stored pesticide containers in their homes, often within the reach of children. Every worker who used paraquat had at least one symptom potentially related to its use, and the prevalences of childhood disorders in the region are abnormally high compared with national averages.

the maternal phase, who are pregnant, are seeking pregnancy or have had a first birth and plan to have additional children; and women who are still fertile, but definitely do not want to ever have a child or another child. The life situations and reproductive problems and goals of these four groups are different, and so are the services they need and the opportunities to serve them most efficiently. Individuals in the first group, who are not yet sexually active, require education and counseling. These services are likely to be best and most efficiently provided in nonclinical settings. For those who are sexually active but wish to postpone childbearing, the timing of their first birth and whether they contract any STDs before then will have great bearing on the opportunities and problems that will affect them throughout their lives. They need information and services related to the prevention, diagnosis and treatment of STDs; emergency contraception; pregnancy diagnosis; and education, counseling and support addressing the range of problems that may arise from the sexual aspects of their lives. Induced abortion is a particularly important issue for this group. According to the local circumstances, services should be available either to provide safe abortions or to treat the consequences of unsafe procedures. Postabortion counseling about contraception is essential in either case. The lives of women in the maternal phase are structured to accommodate their roles as mothers. These women can be served in the context of maternal and child health services and other, related activities. Family planning information and counseling can be provided in association with prenatal and childbirth care; contraception